Medsafe: New Zealand Medicines and Medical Devices Safety Authority

MEDSAFE


New Zealand Medicines and Medical
Devices Safety Authority

Revised: 26 August 2026

Medicines

 

Medsafe Product Detail

File ref: TT50-6706/1
Trade Name Dose Form Strength Identifier
Elevit Film coated tablet New formulation
Sponsor Application date Regulatory status Classification
Bayer New Zealand Limited
P O Box 2825
Shortland Street
Auckland 1140
17/10/2016 Consent given
Approval date:14/11/2019
Pharmacy only

Composition

Component Ingredient Manufacturer
film coated tabletActive 
 Ascorbic acid 85mgDSM Nutritional Products (UK) Ltd
Drakemyre, Dalry
Ayrshire
Scotland KA24 5JJ
UNITED KINGDOM
  CSPC Weisheng Pharmaceutical (Shijiazhuang) Co Ltd
898 Zhongshan East Road
High-tech Industrial Development Zone
RC-050 035
Shijiazhuang City, Hebei Province
CHINA
 Biotin 0.03mgDSM Nutritional Products France
1 Boulevard D'Alsace
Village-Neuf F-68128
FRANCE
 Calcium hydrogen phosphate 407.67mgChemische Fabrik Budenheim
Rheinstrasse 27
Budenheim D-55257
GERMANY
 Calcium pantothenate 6.52mgDSM Nutritional Products (UK) Ltd
Drakemyre, Dalry
Ayrshire
Scotland KA24 5JJ
UNITED KINGDOM
 Colecalciferol 0.025mgDSM Nutritional Products France
1 Boulevard D'Alsace
Village-Neuf F-68128
FRANCE
  DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 Copper sulfate 2.51mgMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  Dr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 Cyanocobalamin 0.0026mgEuroAPI France
Rue de Verdun
76410 Saint-Aubin-lès-Elbeuf
FRANCE
  DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 DL-alpha Tocopheryl acetate 22.35mgDSM Nutritional Products AG
Hauptstrasse 4
Sisseln, Aargau CH-4334
SWITZERLAND
 Ferrous fumarate 182.52mgFerroPharma Chemicals Ltd
6766 Doc
Erdosor
HUNGARY
  Particle Dynamics
2629 South Hanley Road
St Louis
Missouri 63144
UNITED STATES OF AMERICA
 Folic acid 0.8mgDSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 Heavy magnesium oxide 165.25mgKyowa Chemical Industry Co., Ltd.
4035 Hayashida-cho
Sakaide
Kagawa 762-0012
JAPAN
 Manganese sulfate monohydrate 5.72mgMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  Dr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 Nicotinamide 18mgLonza Guangzhou Pharmaceutical Ltd
68, Huangge Dadaobei
Nansha District
Guangzhou, Guangdong Province 511 455
CHINA
 Potassium iodide 0.288mgMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Pyridoxine hydrochloride 2.31mgDSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
 Riboflavin 1.4mgDSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
 Sodium selenite 0.105mgRetorte GmbH Selenium Chemicals & Metals
Sulzbacher Strasse 45
Rothenbach D-90552
GERMANY
 Thiamine nitrate 1.723mgDSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
  DSM Nutritional Products Inc
206 Macks Island Drive
Belvidere
New Jersey 07823-1113
UNITED STATES OF AMERICA
 Zinc citrate trihydrate 35.24mgDr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 Excipient 
 Colloidal silicon dioxide
 Croscarmellose sodium
 Ethanol
 Magnesium stearate
 Microcrystalline cellulose
 Povidone
 Purified talc
 Sepifilm gloss
 Sepisperse Dry White

Production

Manufacturing step Manufacturer
Finished Product TestingPT Bayer Indonesia
Jalan Raya Jakarta Bogor Km 32 Cisalak
Kec. Sukmajaya, Kota Depok
Jawa Barat 16416
INDONESIA
Manufacture of Active IngredientChemische Fabrik Budenheim
Rheinstrasse 27
Budenheim D-55257
GERMANY
 CSPC Weisheng Pharmaceutical (Shijiazhuang) Co Ltd
898 Zhongshan East Road
High-tech Industrial Development Zone
RC-050 035
Shijiazhuang City, Hebei Province
CHINA
 Dr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 Dr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 Dr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 DSM Nutritional Products (UK) Ltd
Drakemyre, Dalry
Ayrshire
Scotland KA24 5JJ
UNITED KINGDOM
 DSM Nutritional Products (UK) Ltd
Drakemyre, Dalry
Ayrshire
Scotland KA24 5JJ
UNITED KINGDOM
 DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 DSM Nutritional Products AG
Hauptstrasse 4
Sisseln, Aargau CH-4334
SWITZERLAND
 DSM Nutritional Products France
1 Boulevard D'Alsace
Village-Neuf F-68128
FRANCE
 DSM Nutritional Products France
1 Boulevard D'Alsace
Village-Neuf F-68128
FRANCE
 DSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
 DSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
 DSM Nutritional Products GmbH
Emil Barrell Strasse 3
Grenzach-Wyhlen D-79639
GERMANY
 DSM Nutritional Products Inc
206 Macks Island Drive
Belvidere
New Jersey 07823-1113
UNITED STATES OF AMERICA
 EuroAPI France
Rue de Verdun
76410 Saint-Aubin-lès-Elbeuf
FRANCE
 FerroPharma Chemicals Ltd
6766 Doc
Erdosor
HUNGARY
 Kyowa Chemical Industry Co., Ltd.
4035 Hayashida-cho
Sakaide
Kagawa 762-0012
JAPAN
 Lonza Guangzhou Pharmaceutical Ltd
68, Huangge Dadaobei
Nansha District
Guangzhou, Guangdong Province 511 455
CHINA
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Particle Dynamics
2629 South Hanley Road
St Louis
Missouri 63144
UNITED STATES OF AMERICA
 Retorte GmbH Selenium Chemicals & Metals
Sulzbacher Strasse 45
Rothenbach D-90552
GERMANY
Manufacture of Final Dose FormPT Bayer Indonesia
Jalan Raya Jakarta Bogor Km 32 Cisalak
Kec. Sukmajaya, Kota Depok
Jawa Barat 16416
INDONESIA
Manufacture of Intermediate ProductDr. Paul Lohmann GmbH & Co. KGaA
Hauptstrasse 2
Emmerthal D-31860
GERMANY
 DSM Nutritional Products AG
Hauptstrasse 4
Sisseln CH-4334
SWITZERLAND
 DSM Nutritional Products Inc
206 Macks Island Drive
Belvidere
New Jersey 07823-1113
UNITED STATES OF AMERICA
 Particle Dynamics
2601 South Hanley Road
St Louis
63144
UNITED STATES OF AMERICA
PackingPT Bayer Indonesia
Jalan Raya Jakarta Bogor Km 32 Cisalak
Kec. Sukmajaya, Kota Depok
Jawa Barat 16416
INDONESIA
NZ Site of Product ReleaseBayer New Zealand Limited
B:Hive Building
74 Taharoto Road
Takapuna
Auckland 0622

Packaging

Package Contents Shelf life
Blister pack, Blister PVC/Polyurethane/PVDC5 tablets36 months from date of manufacture stored at or below 25°C
Blister pack, Blister PVC/Polyurethane/PVDC30 tablets36 months from date of manufacture stored at or below 25°C
Blister pack, Blister PVC/Polyurethane/PVDC100 tablets36 months from date of manufacture stored at or below 25°C

Indications

To supplement maternal dietary intake during pregnancy and lactation

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
17/10/2016New Lower-risk Medicine ApplicationNew lower-risk medicineGranted9/11/2016
31/07/2026Self-Assessable Change NotificationLabelling - G1 (Self assessable)Notified3/08/2026